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临床试验/NCT06705283
NCT06705283招募中不适用

Effects Of Yoga And Whole Body Vibration Training On Women With Stress Urinary Incontinence

Suleyman Demirel University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
39
试验地点
1
主要终点
pelvic floor muscle strength test

研究概览

简要总结

This study aimed to compare the effects of yoga and Whole Body Vibration Training on pelvic floor muscle strength, severity of urinary symptoms and UI-related quality of life in women with UI.

The intervention period for the study was determined as 6 weeks. It has been decided that yoga practice will be done 3 times a week for 45 minutes, and whole body vibration training will be done for 45-55 minutes. The home exercise group will perform the planned exercise protocol every day for 6 weeks.

The results of the study will be evaluated by statistical analysis as a result of the interventions and evaluations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Between the ages of 20-60,
  • •patients with SUI or Mix UI with a predominant SUI component,
  • •patients who have not received treatment with any physical therapy modality in the last 3 months,
  • •patients who signed the informed consent form.

排除标准

  • •Those with neurological diseases that may cause incontinence
  • •Those with prolapse
  • •Those using intrauterine devices
  • •Obesity (BMI >30)
  • •Patients with serious systemic diseases that prevent them from exercising (Cardiovascular disease, COPD, CVO and/or cancer)
  • •Patients with pure urge or mixed UI with a predominant urge component
  • •Patients with a history of thrombosis
  • •Patients who engage in high-intensity sports activities for at least half an hour at least twice a week (tennis, aerobic exercise, running, exercises with body weight).
  • •Patients with neurological or vestibular disease that may cause balance disorders
  • •Patients with grade 3 or 4 knee and/or hip osteoarthritis
  • •Patients with a history of knee and/or hip joint replacement surgery
  • •Patients with kidney or gallbladder stones
  • •Patients with acute disc herniation or spondylolisthesis

研究组 & 干预措施

yoga group

Experimental

This is a group where yoga and home exercise (pelvic floor muscle training) will be done together.

干预措施: yoga and home exercise (Procedure)

whole body vibration training (WBVT) group

Experimental

This is a group where whole body vibration training and home exercise (pelvic floor muscle training) will be done together.

干预措施: whole body vibration training and home exercise (Procedure)

home exercise group

Active Comparator

This is a group where pelvic floor muscle training will be done.

干预措施: home exercise group (Procedure)

结局指标

主要结局

pelvic floor muscle strength test

时间窗: 6 weeks

Pelvic floor muscle strength evaluation will be performed with a perineal EMG biofeedback device with a vaginal probe. After the pressure probe is inserted into the vagina, the patient will be asked to contract the pelvic floor muscles. Contractions will be repeated 3 times and averaged. The obtained value will be recorded in cmH2O.

Numerical Rating Scale

时间窗: 6 weeks

It is used for severity of urinary incontinence. The participant was asked "How much urine do you think you leak?" The question will be asked and the student will be asked to make a mark on the chart that scores between 0-10 points.0 means no urine leakage, 10 means a lot of urine leakage.

International Consultation of Incontinence Society-Short Form

时间窗: 6 weeks

The scale addresses the frequency of UI and how much UI affects a person's life. There are a total of 4 questions, 3 of which are included in the scoring. A total of 0-21 points are given (0: no leakage, 1-5: mild, 6-12: moderate, 13-18: severe, 21: serious urine leakage). As the score increases, the severity of UI and the impact on quality of life increase.

1 hour pad test

时间窗: 6 weeks

• Pad test is an easy-to-perform test that determines the severity of urine leakage objectively. During the implementation of this test, the protocol established by the International Continence Society will be taken as basis. The steps of the protocol are as follows: 0. min: The weight of the clean pad is weighed. It is given to the patient. After wearing the pad, the patient is asked to drink 500 ml of water in a short time. 30 min: walking and climbing stairs 45th minute: Coughing 10 times, sitting down and standing up 10 times, picking up something from the ground 10 times, jumping 10 times, washing hands under running water for 1 minute, running for 1 minute. 60th minute: Weighing the pad taken from the patient again. After the evaluation steps are completed, the amount of urine leakage is calculated by subtracting the weight of the clean pad from the weight of the used pad.

Incontinence Impact Questionnaire-7

时间窗: 6 weeks

There are 7 items in the scale. Items are scored between 0-3, resulting in a total score between 0-21. It is understood that as the score obtained from the scale increases, the severity of UI complaints and quality of life decrease.

Urogenital Distress Inventory-6

时间窗: 6 weeks

It consists of 6 questions. In the scoring of the scale, there are options for each item: 0: not at all, 1: slightly, 2: moderately, 3: very much. Minimum 0 - maximum 18 points can be obtained from UDI-6. The score is determined by converting the points received into a percentage. An increase in the score obtained from the scale indicates that the level of quality of life is deteriorating.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pinar Yasar

Principal Investigator

Suleyman Demirel University

研究点 (1)

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